Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

Study Overview

• Status: Completed
• Conditions: Immune Thrombocytopenic Purpura (ITP)
• Intervention / Treatment: Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Olomouc, Czechia
  • Prague, Czechia
• Germany
  • Giessen, Germany
  • Halle/Saale, Germany
• Hungary
  • Debrecen, Hungary
  • Györ, Hungary
  • Szeged, Hungary
  • Szombathely, Hungary
• Poland
  • Lodz, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >= 18 and <= 65 years
• ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
• Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
• No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
• For females of child bearing potential, use of adequate birth control measures during study participation
• Written informed consent

Exclusion Criteria:

• Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
• Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
• Underlying other autoimmune or lymphoproliferative disorder
• Uncontrolled hypertension
• Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
• Malignancy or history of malignancy
• Documented selective IgA deficiency (<= 10 mg/dL)
• Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
• History of severe adverse reactions to blood and/or blood products
• Pregnancy or lactation
• Positivity for HIV, or HCV antibodies, or HBsAg
• History of unresponsiveness to IVIG defined as a peak increment in platelet count <= 20,000/µL coincident with the last IVIG treatment course prior to study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Who Qualify As Treatment Responders	Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.	Baseline thru Day 15 post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to achieve a platelet count > 50 x 109/L	Screening visit
Time to achieve a platelet count > 50 x 109/L	Day 1 (initiation of treatment)
Time to achieve a platelet count > 50 x 109/L	Day 2
Time to achieve a platelet count > 50 x 109/L	Day 5
Time to achieve a platelet count > 50 x 109/L	Day 8
Time to achieve a platelet count > 50 x 109/L	Day 11
Time to achieve a platelet count > 50 x 109/L	Day 22
Time to achieve a platelet count > 50 x 109/L	Day 15
Time to achieve a platelet count > 50 x 109/L	Day 29 (study termination visit)
Duration of platelet response	Screening visit
Duration of platelet response	Day 1 (initiation visit)
Duration of platelet response	Day 2
Duration of platelet response	Day 5
Duration of platelet response	Day 8
Duration of platelet response	Day 11
Duration of platelet response	Day 15
Duration of platelet response	Day 22
Duration of platelet response	Day 29 (study termination visit)
Maximum Platelet Count	Screening visit
Maximum Platelet Count	Day 1 (initiation visit)
Maximum Platelet Count	Day 2
Maximum Platelet Count	Day 5
Maximum Platelet Count	Day 8
Maximum Platelet Count	Day 11
Maximum Platelet Count	Day 15
Maximum Platelet Count	Day 22
Maximum Platelet Count	Day 29 (study termination visit)
Number of Adverse Experiences	Throughout the study period of approximately 11 months

Collaborators and Investigators

• Sponsor: Baxalta now part of Shire

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2003
• Primary Completion (Actual): December 3, 2003
• Study Completion (Actual): December 3, 2003

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Chronic idiopathic thrombocytopenic purpura
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: 160002